4th Circ. Won't Pause Block On FDA Abortion Pill Limits

By Craig Clough
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Law360 (August 13, 2020, 10:54 PM EDT) -- The Fourth Circuit on Thursday ruled against a request from the U.S. Food and Drug Administration to undo a lower court's injunction that blocks the agency's restrictions on patients' ability to get the so-called abortion pill at a retail pharmacy.

The suit, filed in May by the American College of Obstetricians and Gynecologists and other physician groups, claims that the restrictions on Mifeprex, a pill that ends pregnancy at up to 10 weeks, violate a patient's rights to equal protection of the law under the U.S. Constitution and that COVID-19 only heightened the risk for women seeking the pill.

In a brief order, the panel said it was denying the government's motion for a stay pending appeal.

"Two federal courts have now confirmed what is plain common sense: Forcing patients to travel to a health care facility during a pandemic just to pick up a pill is unjustified and dangerous, particularly for communities of color," said Julia Kaye, staff attorney at the ACLU, in a statement. "As COVID-19 rages across the nation, it is unconscionable that the Trump administration is continuing its quest to subject abortion patients and their families to entirely needless viral risk. The administration should focus on getting COVID-19 under control instead of trying to score political points on the backs of people urgently seeking essential reproductive health care."

The FDA  did not immediately respond to a request for comment. 

U.S. District Judge Theodore D. Chuang determined that the FDA restrictions requiring patients to be handed the medication at a clinic or hospital from a health care provider who has preregistered with the drug's manufacturer were an "undue burden."

In the agency's request for a stay, it told the Fourth Circuit that the lower court "ignored that the requirements apply to a drug pertaining to just one method of abortion that is approved for just a subset of pregnant women (those through 10 weeks pregnant), and that another method of abortion is widely available."

In an amicus brief filed earlier this month, Texas, Indiana and nine other states backed the FDA's request.

The lower court misapplied the U.S. Supreme Court's ruling in June Medical Services v. Russo , which struck down a Louisiana law requiring abortion providers to have admitting privileges at nearby hospitals, by relying on a cost-benefit test for abortion laws, the states said.

Judge Chuang improperly used the cost-benefit balancing test rejected by Chief Justice John Roberts when he should have adhered to the test that considers whether the law imposed an "undue burden" on abortion access, the states said.

The physician groups are represented by Julia Kaye, Anjali Dalal, Ruth Harlow, Rachel Reeves and Jennifer Dalven of the American Civil Liberties Union Foundation and John A. Freedman, R. Stanton Jones, David J. Weiner, Jocelyn A. Wiesner, Andrew Tutt and Gina Colarusso of Arnold & Porter.

The FDA is represented by Joshua Dos Santos of the U.S. Department of Justice's Civil Division and Acting Assistant Attorney General Ethan P. Davis and Senior Counsel to the Assistant Attorney General Sophan Joshi.

The case is American College of Obstetricians and Gynecologists et al. v. U.S. Food and Drug Administration et al., case number 20-1824, in the U.S. Court of Appeals for the Fourth Circuit.

--Additional reporting by Kevin Stawicki. Editing by Jay Jackson Jr.

For a reprint of this article, please contact reprints@law360.com.

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Case Information

Case Title

Amer College of Obstetricians v. FDA

Case Number



Appellate - 4th Circuit

Nature of Suit

2440 Other Civil Rights

Date Filed

July 29, 2020

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